A Phase III Study of MEK162 versus Standard Chemotherapy in Patients with Recurrent or Persistent Low-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: The MILO Study

Protocol
13-098
Full Title
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum
Phase
III
Purpose

The purpose of this study is to compare the effectiveness of the investigational drug MEK162 with standard chemotherapy in women with low-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has returned after being treated or persists despite therapy. MEK162 works by inhibiting a protein called MEK1/2, which can fuel cancer cell growth. It is taken orally (by mouth).

Patients will be randomly assigned to one of two groups: MEK162 (two-thirds of the patients) or standard chemotherapy with liposomal doxorubicin, paclitaxel, or topotecan (the remaining one-third of patients).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have low-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has returned after being treated or persists despite therapy.
  • Patients should have received at least one prior regimen of platinum-containing therapy, but no more than three previous regimens of chemotherapy.
  • Patients must have recovered from the serious side effects of prior treatment before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rachel Grisham at 646-888-4653.

Disease(s)
Locations
Related Diseases